Medical device licence · 76630 · Class 2
VIEWSITE BRAIN ACCESS SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 19, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76630
- Licence holder
- Vycor Medical Inc.Boca Raton, FL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- March 19, 2008
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BRAIN ACCESS SYSTEM - EC MODEL
- BRAIN ACCESS SYSTEM - SF MODEL
- BRAIN ACCESS SYSTEM - TC MODEL
- BRAIN ACCESS SYSTEM WITH ALIGNMENT CLIP
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.